Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250263
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2005-11-06
Brief Title:
A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite D Pteronyssinus Allergy
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite D Pteronyssinus Allergy
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Allergic diseases represent a major health issue worldwide Mainstay treatment is allergen avoidance and pharmacotherapy for symptom relief Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy and can modify the course of disease However use of this treatment is restricted by the high risk of adverse events especially in asthmatics Other better tolerated routes of allergen administration than the current conventional subcutaneous route SCIT have been investigated including sublingual SLIT However the immune parameters of SLIT have not been examined We propose conducting a randomised placebo-controlled study of a commercially-available SLIT for house dust mite HDM allergy to investigate induction of relevant T cell regulatory immune mechanisms The first year will be followed by an optional open label extension period Immunoregulatory cytokine synthesis and T cell phenotype and function real time PCR and flow cytometry will be examined This project will provide important fundamental knowledge on which to base improved and greater application of this potentially curative treatment for allergy SLIT has the potential advantage of home administration and suitability for patients with asthma who are currently unable to access many of the allergen desensitising regimens
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None